Hormonal or copper intra-uterine devices (IUDs) or intra-uterine systems (IUSs) are used as a common method of anti-conception and/or for treatment of menorrhagia and/or for treatment of other conditions. The term IUD (intra-uterine device) will be used herein to refer to both IUDs and IUSs.
IUDs are commonly T-shaped, having an elongated member (from hereon called the central rod) having at one end a transverse member comprising two wings. The wing tips (also known as hands) at the end of these wings may be rounded off. The central rod and the wings form a substantially T-shaped piece when the device is positioned in the uterus. In addition to a T-shape, IUDs also exist in other shapes such as a ring, a rod, a ‘7’ or an ‘S’.
The intra-uterine device (IUD) can be partially or wholly made from plastic material, biocompatible material or metal, such as silver or gold, and sometimes contains a copper wire wound partly around it. The copper ions that are released act as a spermicide, further enhancing the contraceptive properties of the IUD. Intra-uterine devices are also capable of releasing drugs, hormones (such as levonorgestrel) or other active agents to treat menorrhagia or other conditions.
Intra-uterine devices often have a withdrawal string attached to the central rod of the device. After insertion of an IUD, the string remains positioned within the cervix for a period of up to 5 to 10 years to facilitate extraction of the IUD by the health care provider. The withdrawal string also allows the patient to check whether the IUD is still correctly in place.
The IUD and string are introduced into the uterus by means of a separate inserter device. Several types of inserter devices exist in the prior art. Most common inserters are constructed for introducing the IUD in a contracted and covered state during insertion in order to facilitate the introduction of the IUD into the cervical canal. Typically, this covered state is provided by a protective tube, in which the IUD can be housed during insertion. In addition, the protective tube usually has a rounded, blunt end which will pass through the cervical canal easily and which will not damage the fundus of the uterus upon contact therewith.
However, because of the delicate nature of the insertion procedure, existing inserters are often inefficient in handling, which is mainly due to the various moving parts. Production costs are relatively high because of the different parts that need to be assembled correctly. Furthermore, the more complicated the device assembly, the higher the demands and costs are for quality control.
Several IUD inserters contain a stopping mechanism, facilitating correct positioning of the IUD within the uterus. However, these stops are discrete and only tailored to the insertion of one particular IUD with a specific size and shape. Therefore, the same inserter cannot be used to insert an IUD that differs in shape or size. Discrete stops also prevent fine-tuning by the medical practitioner, who is confined to a limited set of specific configurations.
Therefore, the main objective of the current invention is to provide an inserter device suitable for inserting a conventional intra-uterine device (IUD) connected to a withdrawal string, said inserter device being inexpensive to produce and easy to use, yet still ensuring accurate and safe insertion of the IUD. Furthermore, said inserter device should be practical for insertion of a range of IUDs, without any structural modifications to the inserter necessary.
It is an objective of the current invention to provide an inserter that is inexpensive and easy to produce on a large scale. Another objective of the current invention is to provide an inserter that comprises a minimum of moving parts and separate parts. Another objective of the current invention is to provide an inserter that is low cost and can therefore provide contraception to a global market, third-world countries in particular. Another objective of the current invention is to provide an inserter unlikely to break, safe to use and unlikely to harm the patient. Another objective of the current invention is to provide an inserter that is easy to use, therefore allowing for lesser trained professionals to insert the device. Another objective of the current invention is to provide an inserter that allows correct positioning of the IUD within the uterus. Another objective of the current invention is to provide an inserter that provides an infinite number of insertion positions, whereby the correct insertion position can be tailored to the IUD to be inserted. Another objective of the current invention is to provide an inserter that allows easy manipulation and fixation of the withdrawal string during the insertion procedure. Another objective of the current invention is to provide an inserter that is designed primarily for the insertion of conventional devices which are to be inserted in a compressed configuration. The invention as described in this application, and preferred embodiments thereof, will comply with one or more of the above-mentioned objectives.